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A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis

NCT ID: NCT05265273

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-20

Study Completion Date

2026-06-26

Brief Summary

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The purpose of this study is to determine the effect of nipocalimab on total serum immunoglobulin G (IgG) in pediatric participants 2 to less than (\<) 18 years of age (globally) and 8 to \<18 years of age (for Unites Stated (US) sites only), the safety and tolerability of treatment with nipocalimab in children and adolescents and to evaluate the pharmacokinetics (PK) of nipocalimab in children and adolescents with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing, stable standard-of-care therapy.

Detailed Description

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Conditions

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Myasthenia Gravis

Keywords

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Pediatric

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nipocalimab

Participants age 2 to less than (\<) 18 years of age (globally) and 8 to \<18 years of age (for US sites only) will be divided into 2 cohorts as per their age-adolescents 12 to \<18 years and children 2 to \<12 years and will receive nipocalimab once every two weeks for 24 weeks. After Week 24, all participants will have the option to enroll in long term extension (LTE).

Group Type EXPERIMENTAL

Nipocalimab

Intervention Type DRUG

Nipocalimab will be administered as an IV infusion.

Interventions

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Nipocalimab

Nipocalimab will be administered as an IV infusion.

Intervention Type DRUG

Other Intervention Names

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M281/JNJ-80202135

Eligibility Criteria

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Inclusion Criteria

* Age: For US sites only: 8 to \< 18 years
* Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized myasthenia gravis (gMG) as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class IIa/b, IIIa/b, or IVa/b at screening
* Has a positive serologic test for acetylcholine receptor (anti-AChR) antibodies or muscle-specific tyrosine kinase (anti-MuSK) antibodies at screening
* A participant using herbal, naturopathic, traditional Chinese remedies, ayurvedic or nutritional supplements, or medical marijuana (with a doctor's prescription) is eligible if the use of these medications is acceptable to the Investigator. These remedies must remain at a stable dose and regimen throughout the study
* Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol
* Participants should have a body weight and body mass index between 5th and 95th percentile for age and sex. Obese participants greater than 95th percentile and underweight participants below 5th percentile may participate following medical clearance
* A female of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at Screening and a negative urine pregnancy test at Day 1 prior to administration of study intervention

Exclusion Criteria

* Has a history of severe and/or uncontrolled hepatic (example, viral/alcoholic/ autoimmune hepatitis/ cirrhosis/ and/or metabolic liver disease), gastrointestinal, renal, pulmonary, cardiovascular (including congenital heart diseases), psychiatric, neurological musculoskeletal disorder, any other medical disorder(s) (example, diabetes mellitus), risk factors for thrombosis events (example, a history of venous thromboembolism \[VTE\] or antiphospholipid syndrome, or a personal or family history of heritable coagulation disorder such as factor V leiden, protein S or protein C deficiency, atrial fibrillation/flutter, major orthopedic surgery or significant trauma that may increase the risk of VTE, is expected to be immobilized for prolonged periods of time), or has clinically significant abnormalities in screening laboratory, that might interfere with participant's full participation in the study, and/ or might jeopardize the safety of the participant or the validity of the study results
* Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her generalized myasthenia gravis (gMG), or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
* Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the Active treatment Phase of the study
* Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis to therapeutic proteins (example, monoclonal antibodies)
* Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Phoenix Children's Hospital

Phoenix, Arizona, United States

Site Status RECRUITING

Childrens Hospital Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States

Site Status RECRUITING

UCSF Benioff Children's Hospital

San Francisco, California, United States

Site Status RECRUITING

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status RECRUITING

University of South Florida Morsani Center for Advanced Healthcare

Tampa, Florida, United States

Site Status RECRUITING

University of Kansas Medical Center

Lawrence, Kansas, United States

Site Status COMPLETED

C.S. Mott Children's Hospital

Ann Arbor, Michigan, United States

Site Status RECRUITING

Penn State Milton S Hershey Medical Ctr

Hershey, Pennsylvania, United States

Site Status RECRUITING

Childrens Hospital Of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status TERMINATED

Nagano Children's Hospital

Azumino-shi, , Japan

Site Status RECRUITING

Chiba University Hospital

Chiba, , Japan

Site Status RECRUITING

University of Miyazaki Hospital

Miyazaki, , Japan

Site Status RECRUITING

Hyogo College of Medicine Hospital

Nishinomiya-Shi, , Japan

Site Status RECRUITING

Saitama Prefecture Children's Medical Center

Saitama Shi, , Japan

Site Status RECRUITING

Tokyo Women's Medical University Hospital

Shinjuku-ku, , Japan

Site Status RECRUITING

Leiden University Medical Center

Leiden, , Netherlands

Site Status RECRUITING

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Site Status RECRUITING

Countries

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Canada United States Japan Netherlands Poland

Central Contacts

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Study Contact

Role: CONTACT

Phone: 844-434-4210

Email: [email protected]

Other Identifiers

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80202135MYG2001

Identifier Type: OTHER

Identifier Source: secondary_id

2021-002479-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2022-502539-21-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR109137

Identifier Type: -

Identifier Source: org_study_id